MAUDE Adverse Event Report: MAQUET SAS XTEN; LIGHT, SURGICAL, CEILING MOUNTED

Model Number ARD568231210C

Device Problems Corroded (1131); Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided upon results of investigation.Device not returned to manufacturer.

Event Description

On (b)(6) 2020 getinge became aware of an issue with one of our surgical lights ¿ xten.As it was stated paint peeling and rust was noticed on forks of the device.No information about any injury has been provided, however we decided to report this case based on potential and in abundance of caution as any paint or rust particles falling from the device might led to contamination.

Manufacturer Narrative

Getinge became aware of an issue with x-ten surgical light.As it was stated by the customer, the paint peeling and rust was noticed on forks of the device.There was no injury reported.The affected device is xten surgical light with the catalog number given as ard568231210c.Affected parts are forks with the serial numbers (b)(6).The forks in the facility was installed in year 2007.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that in the past the reported scenario has never led to serious injury, nor death.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition (b)(4).This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendations would have been followed the incident could have been avoided.

Event Description

Manufacturer reference number (b)(4).

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: XTEN
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 11055855
• MDR Text Key: 223162245
• Report Number: 9710055-2020-00519
• Device Sequence Number: 1
• Product Code: FSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARD568231210C
• Device Catalogue Number: ARD568231210C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/08/2021; 03/18/2021
• Supplement Dates FDA Received: 02/02/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1